Woodcock Outlines Priorities For Next US FDA Commissioner
Along with the pandemic, user fees, IT upgrades and nutrition issues should be at the top of the list, the acting commissioner said.
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A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.
Pfizer’s Comirnaty: Emerging Myocarditis Signal Drew Flurry Of Attention During Compressed BLA Review
Multiple offices within CBER worked to get a handle on the myocarditis issue in the midst of a three-month review of the COVID vaccine, with US FDA staff undertaking a quantitative benefit-risk assessment and negotiating with Pfizer on postmarket safety studies.
The cardiologist seeking another term as FDA commissioner has been working in the pharma industry since leaving the post, but Senators have tended not to question nominee's work history extensively during previous confirmation hearings.